NCT03790800

Intensive Ambulance-delivered Blood Pressure Reduction in Hyper-Acute Stroke Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,425 (actual)
• Sponsor: The George Institute for Global Health, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A multicentre, ambulance-delivered, prospective, randomized, open-label, blinded endpoint (PROBE) study to assess the effects of hyperacute intensive blood pressure (BP) lowering initiated in ambulance setting on (i) functional outcome in patients with acute stroke (ii) safety in patients with confirmed acute stroke and other conditions that were initially suspected as acute stroke (i.e. stroke mimic).

Detailed description

As an investigator initiated and conducted, multicentre, ambulance-delivered, prospective, randomised, open-label, blinded outcome (PROBE) study. INTERACT4 aims to evaluate the effects of functional outcome according to an ordinal analysis of the full range of scores on the mRS, the safety in all randomised patients; reperfusion treatment (thrombolysis and/or thrombectomy) related symptomatic ICH (sICH, according to standard definitions), infarct size, the time to and overall rate of reperfusion treatment in AIS patients; hematoma volume and early expansion in ICH.

Conditions

• Stroke, Acute
• Cerebrovascular Disorders

Interventions

Type	Name	Description
DRUG	urapidil	A standard treatment regime based on intravenous (IV) bolus of 25mg urapidil administered over 1 minute. For those patients initial systolic blood pressure 180, another 25mg urapidil bolus will be given if the systolic blood pressure level persists \>150 after 5 minutes.

Timeline

• Start date: 2020-03-20
• Primary completion: 2023-11-23
• Completion: 2023-11-30
• First posted: 2019-01-02
• Last updated: 2025-03-26

Locations

4 sites across 1 country: China